Healthcare Industry News: bivalirudin
News Release - August 7, 2007
The Medicines Company Submits Angiomax(R) (Bivalirudin) sNDA to Expand Label to Include ACUITY DataACC/AHA recommend Angiomax in updated practice guidelines
PARSIPPANY, N.J.--(HSMN NewsFeed)--The Medicines Company (NASDAQ: MDCO ) today announced it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for Angiomax® (bivalirudin) in support of a proposed new dosage for immediate treatment of patients with acute coronary syndromes (ACS). Angiomax is currently approved for patients undergoing percutaneous coronary intervention (PCI), commonly referred to as angioplasty.
The Medicines Company also noted that new guidelines released yesterday by the American College of Cardiology (ACC) and the American Heart Association (AHA) grant a Class I (level of evidence B) recommendation that Angiomax "should be administered" as one of the choices for anticoagulant therapy for patients with unstable angina (UA) and non-ST-elevated myocardial infarction (NSTEMI) who are selected to receive an invasive strategy. The guidelines note that an invasive strategy should be considered for patients with high risk characteristics. The guidelines state anticoagulant therapy should be given with antiplatelet therapy, such as aspirin, thienopyridines, and/or GP IIb/IIIa inhibitors. UA and NSTEMI are the most common forms of acute coronary syndromes (ACS).
"On the strength of the ACUITY trial results, Angiomax is included in U.S. ACS guidelines for the first time," said John Kelley, President and Chief Operating Officer of The Medicines Company "The clinical importance of the ACUITY data have supported publications in three leading, peer-reviewed medical journals and recommendations for Angiomax in the management of ACS both in the U.S. and Europe."
An application for marketing authorization is currently under review with European regulatory authorities to expand the approved uses of Angiox® to include the emergency use of Angiox in ACS patients undergoing PCI. Angiox is the name under which Angiomax is marketed in Europe.
About the ACC/AHA ACS Guidelines
Of the three possible Classes, a Class I indication is the highest ranking, designating a treatment that is useful and effective based on evidence and/or general expert agreement. The "B" designation is the second highest ranking of the weight of evidence, and indicates supporting data were from a limited number of randomized trials that involved small numbers of patients, and/or from careful analyses of non-randomized studies or observational registries.
Class II designates treatments supported by conflicting evidence or divergent expert opinion, and Class III designates treatments that are not useful or effective - and in some cases may be harmful - based on evidence or expert opinion. Designation "A" is used if data were based on multiple randomized clinical trials involving large numbers of patients, and "C" is used when expert consensus was the primary basis for the recommendation.
ACUITY was one of the largest ACS clinical trials ever conducted to evaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients in 450 centers worldwide. The trial design employed an early invasive strategy (angiography within 72 hours), starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard therapy of heparin (unfractionated or enoxaparin) plus a drug called a glycoprotein IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the "Angiomax alone" treatment group. In the Angiomax alone group, selective use of GPIIb/IIIa inhibitor was permitted in limited circumstances, and occurred in less than 10% of patients in the ACUITY trial. Based on results of coronary angiography and the clinical judgment of the treating physician, patients were treated for ACS through medical management, bypass surgery or PCI.
The ACUITY one-year results were recently presented as late-breaking findings by investigators at the 2007 i2 Summit at the 56th Annual Scientific Session of the American College of Cardiology. Collectively, the data showed that ACUITY met all primary one-year endpoints for the Angiomax alone treatment group and confirmed previously published 30-day findings.
ACS includes a range of conditions, such as chest pain and heart attack, which are caused by insufficient blood supply to the heart due to blockages in coronary arteries, usually caused by blood clots. Patients with ACS symptoms are at significant risk for heart attack or death. Each year in the United States, 5 million people go to the emergency department with chest pain, of which approximately 2 million are identified with UA and NSTEMI ACS.
About Angiomax® (bivalirudin)
Angiomax is currently approved in the U.S. and the European Union, as well as several other territories. Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated comparable efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications persist even in high-risk patients.
In the U.S., Angiomax with provisional GP IIb/IIIa inhibition is indicated in patients undergoing PCI and in patients with, or at risk of, HIT/HITTS undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO ) is committed to delivering innovative, cost-effective acute care hospital products in the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. In July 2007 the Company terminated its distribution arrangements with Nycomed and reacquired from Nycomed all development, commercial and distribution rights held by Nycomed for Angiox® (bivalirudin) in Europe. The Company also has two products in late-stage development, Cleviprex(TM) (clevidipine) and cangrelor. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company is successful in extending the term of the principal patent covering Angiomax, the extent of the commercial success of Angiomax, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, risks associated with the establishment of international operations, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on May 9, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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